AccessGUDID - DEVICE: DENTSPLY Tulsa Dental Specialties (10817417020081)

GUDID

Device Identifier (DI) Information

Brand Name: DENTSPLY Tulsa Dental Specialties
Version or Model: AE-250-30-T
Commercial Distribution Status: In Commercial Distribution
Catalog Number: AE-250-30-T
Company Name: ASEPTICO, INC.

Primary DI Number: 10817417020081
Issuing Agency: GS1
Commercial Distribution End Date: June 15, 2033
Device Count: 1
Labeler D-U-N-S® Number*: 016853348 *Terms of Use

Device Description: HANDPIECE, DIRECT DRIVE, AC-POWERED (MICROMOTOR) Accessory to AEU-27T.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38347	Dental power tool system handpiece, line-powered	A hand-held, mains electricity (AC-powered) dental device that includes a chuck or collet for attaching a dental endpiece (e.g., drill bit, bur, reamer, saw blade, polishing disk) intended to be used in dentistry to bore/excavate bones, teeth, and tough tissues. It is powered by a low-voltage electric micro-motor (e.g., 24 volt) that is an integral part of the device; the endpiece(s) are not included. It is typically connected through the dental delivery system or a freestanding independent control unit. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EKX	Handpiece, Direct Drive, Ac-Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Atmospheric Pressure: between 69.7 and 101.33 KiloPascal
Handling Environment Atmospheric Pressure: between 69.7 and 101.33 KiloPascal
Handling Environment Humidity: between 10 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Handling Environment Temperature: between 10 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 1 Pound

Device Record Status

Public Device Record Key: bdc83551-89c0-409e-8d65-a05110146de2
Public Version Date: October 16, 2019
Public Version Number: 4
DI Record Publish Date: June 15, 2018